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Insight Molecular Diagnostics Inc. (IMDX)

Q4 2016 Earnings Call· Mon, Mar 6, 2017

$4.21

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Transcript

Operator

Operator

Good day and to the OncoCyte conference call to discuss the latest developments, in addition to the Fourth Quarter and Full Year 2016 Financial Results. Today’s conference is being recorded. At this time, I would now like to turn the conference over to, Mr. Michael Polyviou. Please go ahead sir.

Michael Polyviou

Management

Thank you, Cody. We appreciate everyone joining us on this afternoon's conference call and webcast to review this morning’s press release announcing the successful result in the company’s lung cancer diagnostic test, R&D validation study as well as the fourth quarter and full year results and other recent developments. The fourth quarter results were announced on February 27 and the news release is available on the OncoCyte website. On the call today are members of OncoCyte's senior management team, including Bill Annett, President and Chief Executive Officer. Before turning the call over to Bill, I would like to remind you that during the course of this conference call the company will make some projections and forward-looking statements regarding future events. We encourage you to review the company’s filings with SEC including without limitation the company’s Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events differ materially from those described in this forward-looking statements. These factors may include without limitation, risks inherent in the development and/or the commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory certifications, uncertainty in the training reimbursement authorization from third party payers, need and ability to obtain future capital and maintenance of intellectual property rights. Therefore, actual results may differ materially from what is expressed or implied by these forward-looking statements. OncoCyte expressly disclaims any intent or obligation to update these forward-looking statements except as otherwise may be required by applicable law. With that, I would like to turn the call over to Bill Annett, President and Chief Executive Officer. Bill, please go ahead.

Bill Annett

Management

Thank you, Michael and welcome everyone to our conference call to discuss the successful outcome of our 300-patient lung Cancer diagnostic test, R&D valication study as well as the Q4 and full year 2016 results. Today I am joined by Lyndal Hesterberg, our Senior Vice President, Research and Development; Kristine Mechem, our Vice President of Marketing; and Russell Skibsted, our Chief Financial Officer. They will be available during the question-and-answer session. So I’m conducting today’s call from Boston, where I’m attending the Cowen Health Care Conference and I’m presenting the company on Wednesday morning at 9.20 AM, rest of the team is in our Alameda, California Headquarters. With that let me now focus on the clinical progress. For the purposes of today’s call, I’ll first review the key developments regarding our lung cancer test and discuss our breast cancer test. This morning we reported the successful results of the R&D validation study of our lung cancer diagnostic test, a critical step in the development of our first product. While the key performance metrics of our diagnostic cannot be revealed until they’re presented at the American Thoracic Society Meeting in May, we’ve now reached the point where our prediction algorithm is set and we’re ready to move to the final stage before commercial launch. The data from the study exceed our endpoints and the levels that we believe are necessary for a commercially successful test and as a result OncoCyte is moving forward with plans to launch the lung cancer diagnostic test during the second half of 2017. The analysis of the samples that we collected from approximately 300 patients at 26 oncology centers in the U.S., produced results that are consistent with those presented by the Wistar Institute at the CHEST Conference in October 2016. The data will be presented…

Operator

Operator

[Operator Instructions] We’ll take our first question from [indiscernible].

Unidentified Analyst

Analyst

Yes, thank you. Bill, in cognizant that you need to be careful about what you can disclose with respect to the study due to the presentation coming up in May, in using the language that you did that the results were consistent with the Wistar results, can we infer from that that given a similar AUC and similar setting of sensitivity at 90% that the specificity is within a couple of percent plus or minus of the number posted by Wistar?

Bill Annett

Management

Thanks, Kay. As we mentioned, the data is embargoed until the presentation by Dr. Anil Vachani at the American Thoracic Society Conference. Now, so we can't go into the details of it. All that we can say really is that our data is very consistent with what Wistar has reported out.

Unidentified Analyst

Analyst

Okay. I appreciate that. And, Bill, just in terms of the 2017 operating expense, any guidance you can provide there would be helpful. Obviously, 2016 you had basically 11 million kind of split evenly between R&D and SG&A. As we think about 2017 with the ongoing and planned clinical studies along with the ramping up on the commercial side, can you give us any sense of what the overall OpEx in 2017 relative to ‘16 might look like?

Bill Annett

Management

Yeah, but we're not giving any guidance at this time about our potential expenses in 2017. I think it is fair to say that as we go into launch our commercial expenses, we’ll be ramping up. Again as we mentioned, we're trying to do this in a very cost-effective way. We're going to have a relatively small sales force, which we believe is not only prudent from a financial standpoint, but it's what we need in order to effectively detail the relatively small number of specialists in this field. So, we will spend appropriately in terms of what we need to get good penetration of the market, but we're certainly not going to overspend or hire a huge commercial infrastructure.

Unidentified Analyst

Analyst

Okay. That’s all I had. Thanks.

Bill Annett

Management

Thank you, Kay.

Operator

Operator

Thank you. We’ll now move on to our next question from Paul Knight with Janney Montgomery.

Paul Knight

Analyst · Janney Montgomery.

Hi, Bill. Can you talk about your shooting for this long approval here in two each, , can you talk about addressable size and then specifically talk about commercial reimbursement process? Do you think it's a year or 18 months? Give us the gauge on where you see this market initially under CMS and then timing on commercial?

Bill Annett

Management

Sure. So, as we mentioned, we are planning on launching in the second half of the year as soon as we finished our clinical validation study. And as I mentioned in the discussion here, our first intended use is going to be Lung RADS 4. That again is nodules which are eight millimeters and larger. And those today, as we mentioned, we think that there is that that's about 4% of the overall population with long nodules. So, it's probably in the 400,000 to 600,000 patients per year range. Now, assuming that all patients got their screening test, number of screening tests that is going on is increasing fairly rapidly, so it is a rapidly growing market. So, that bakes to the potential addressable market. As we also mentioned, given that we are doing studies, our studies with lung nodule sizes right down to five millimeters, we believe that we have a potential second indication in Lung RADS 3 the five to eight millimeter lung nodules and that of course is another potentially up to 800,000 patients. That gets us to that 1.4 million patients per year total addressable market number. I think your second question was about reimbursement. Reimbursement, as you know, is in the lung space, in the diagnostic space in general, is it can take a number of years. And what's really important is that we are building out our product development plans, our R&D plans, as well as our commercial plans to give the highest potential opportunity for reimbursement. So, the way that CMS and other insurance companies look at this, they want to see not only the strong clinical validation studies, which we hope to complete this year, but also the ongoing clinical utility studies, which would show after launch are the doctors actually avoiding the biopsy. So, we are planning and doing enough of those that we will give the insurance companies, the CMS, the payers in general what it is that the data that they need. So, I think that it's difficult to predict the time, but we have seen with other companies with tests of this sort is it can take up to two to three years to get the reimbursement. There will be some reimbursement as we said before that. We also hope to get the coverage with data development from CMS, which is at their discretion, but that is something, which could come potentially a little faster. So, those are - I think we're facing the same kind of reimbursement challenges that the rest of the industry does, but we are building out our science and our commercial practices to try to maximize that opportunity.

Paul Knight

Analyst · Janney Montgomery.

Thank you.

Operator

Operator

[Operator Instructions] We’ll now take our next question from Raymond Myers with Benchmark.

Raymond Myers

Analyst · Benchmark.

Yeah, thank you, Bill. Congratulations on this milestone.

Bill Annett

Management

Thank you.

Raymond Myers

Analyst · Benchmark.

My first question and I understand if you can't answer it at all, but I understand that there was a preliminary analysis of the first hundred patients in this lung study and then there was a continuation of enrolment beyond that to the full 300, so you have 100 patients and 300 patients. Was the 100 patients meaningfully different than the study overall in terms of sensitivity and specificity?

Bill Annett

Management

Yeah. So, we can't go into that again because of the data embargo, but basically to your question, the deadline for submission of abstracts for ATS was I believe it was December. And at that point in time we had done the analysis of the first 100 patients and we did submit an abstract based on that and were accepted. And now Dr. Anil Vachani who is the lead author on the study, is going to be presenting. And we briefed him fully on the 300-patient study, so he has got all of the data. And so, he will be presenting the data at ATS in May.

Raymond Myers

Analyst · Benchmark.

Okay. Great. Well, we certainly look forward to that. I know you've been speaking with payers, you mentioned doing studies and samples of payer groups to understand their interest and willingness to pay for the studies you're bringing to market. After those discussions, what reimbursement rate are you now targeting for the lung test?

Bill Annett

Management

So, we're trying to get a reimbursement rate that is based on two things. So, one factor is taking a look at the pricing that other similar oncology diagnostic tests or the MAAA test and the multiple analyte algorithmic analysis tests are getting currently and if you look at tests like [indiscernible] and Genomic Health’s Oncotype DX. You're looking at $3000 plus reimbursement for those kinds of tests. The second thing we look at is the comparators, meaning it’s the health care economic view of the world, which is how much money can we save the health care system, CMS, and the insurance companies with our pricing. And what we found in our health care economic study is that if we position our test, our pricing at something like 20% to 25% of the cost of a biopsy, it does provide significant cost savings to the insurance companies. And as we mentioned, the recent Medicaid study put the all-in, the full costs of lung biopsies on average at just under $15,000. So, those two factors, those two variables are helping us to determine the pricing.

Raymond Myers

Analyst · Benchmark.

Okay. Very good. And then one last question if I may. Can you - a bit better sense of the timing and magnitude of the sales and marketing budget? We understand that it's not a large scale expense. But when do we expect that expense to start to layer in? And give us some sense of how many people you intend to be employing, say, by the end of next year - at the end of 2017?

Bill Annett

Management

So, at the end of this year 2017?

Raymond Myers

Analyst · Benchmark.

Yeah, sorry, that’s this year.

Bill Annett

Management

Yeah. Okay. So, again we haven't made any announcements yet about our plans in terms of specific numbers, but we will start off with a very small sales team, handful of people. And I think that's all we will need. We will scale that up over time. And so, again be relatively modest and I would say that we're going to cater then in the call today that we posted the half a dozen job descriptions on our website today. So, we're going to begin the process of hiring. We're not going to hire all those people at once, but over this year we are going to be developing the various areas that I mentioned, the marketing sales, sales operations, and so on. So, we will be ramping up our commercial spend cautiously, but again not understanding we want to spend enough so that we can have an effective watch, but not over spending, so that we exceed our financial capabilities.

Raymond Myers

Analyst · Benchmark.

That's great. Thank you. And then last question is as you characterize the relative either difficulty or critical risk and the studies remaining for lung, how do they compare to the studies you've already now completed?

Bill Annett

Management

Okay. Well, I would say, as we mentioned, there are some in-house internal studies like the happening in the CLEA lab. And then there is the clinical validation study, which is the final study of 300 plus blinded prospectively collected samples. And I would say in science you can never tell until it's done. However, I think it's safe to say that we are very happy to see that our independent study got results, which were consistent with what Wistar got. That's a very good sign. Lyndal, do you have any other thoughts you might want to add there?

Lyndal Hesterberg

Analyst · Benchmark.

I think going forward it would be what’s pretty much standard in the industry is that as part of moving the test system into the clinical lab, we have to comply with all the Clinical and Lab Standards Institute guidelines and those will be under - under way - sorry, we will be doing those studies over the next few months as well.

Raymond Myers

Analyst · Benchmark.

Lyndal, I believe those studies are fairly straightforward. I think it’s the clinical validation study that we're looking to see with the final results.

Lyndal Hesterberg

Analyst · Benchmark.

Correct. That is - the clinical validation study is the one that then demonstrates the performance of the essay in the clinical laboratory under what we expect to be commercial circumstances and conditions.

Raymond Myers

Analyst · Benchmark.

Great. And are those conditions much different than what you had experienced in that study that is just announced?

Bill Annett

Management

Lyndal?

Lyndal Hesterberg

Analyst · Benchmark.

Yes. The conditions themselves won’t be other than now, it will be the fully - the full CLEA staff with all the CLEA-licensed personnel performing the operations.

Bill Annett

Management

Yeah, so my understanding is very similar.

Raymond Myers

Analyst · Benchmark.

Okay. All right, very good. Thank you and congratulations.

Bill Annett

Management

Thank you.

Operator

Operator

Thank you. And that does conclude today's question-and-answer session. I would now like to turn the conference back over to Mr. Bill Annett for any additional or closing remarks.

Bill Annett

Management

Well, thank you again very much everyone for attending our conference call today and I look forward to updating you on our continued progress.

Operator

Operator

Thank you. That does conclude today's conference. Thank you all for your participation. You may now disconnect.